Device
"The PINION™ PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle
Manufacturer
MERIL ENDO SURGERY PRIVATE LIMITED
MERIL ENDO SURGERY PRIVATE LIMITED
Model: PNCS101014BD
DI: 08904255257436
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
"The PINION™ PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle
on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PGA-PCL Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of poly (glycolide-co-caprolactone). PINION™ PGA-PCL Knotless Suture is provided undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.25 % by weight of the suture in sizes USP (EP) 4-0 (1.5), 3-0 (2), 2-0 (3) 0 (3.5), 1 (4) & 2(5). It is supplied with the attached stainless steel surgical needles. The polymer has been found to be nonantigenic, nonpyrogenic and eliciting only a slight tissue reaction during absorption. The PINION™ PGA-PCL Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots. The USP designations for diameter are applicable to the PINION™ PGA-PCL Knotless Suture material prior to barbing. After the creation of barbs, the PINION™ PGA-PCL Knotless Suture is identified as one size smaller than the non-barbed suture. This modification reduces the tensile strength of the suture similar to effect of knot tying in non-barbed suture. Therefore, the straight pull tensile strength of the PINION™ PGA-PCL Knotless Suture is comparable to the USP knot pull tensile strength for a non barbed suture of the equivalent size."
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0d0643e7-9093-4b64-ba6a-e8869dae1d14
Distribution Status:
In Commercial Distribution
DUNS Number:
870914838
Device Count:
12
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
18904255257433
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08904255257436
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 60480
Name: Barbed polyester suture, non-antimicrobial
Definition:
A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) intended to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. It does not include antimicrobial agents/materials. This is a single-use device.
FDA Product Codes
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
Premarket Submissions
Submission Number:
K252644
Supplement Number:
000