POLYSORB SYNTHETIC ABSORBABLE SUTURE— 510(k) K895579

Clearance details

Applicant

United States Surgical, A Division of Tyco Healthc

Product code

Code GAN

Device class

Class 2

Regulation

21 CFR 878.4830

Advisory panel

General, Plastic Surgery

Date received

1989-09-15

Decision date

1990-07-05

Decision

Substantially Equivalent for Some Indications

Clearance type

Traditional

Location

Norwalk, CT, US

• K003015 — SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD2000-12-15
• K964072 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED1996-12-18
• K960653 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)1996-03-28
• K951231 — ORTHOPEDIC PACKS1995-12-01
• K920978 — ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED1994-02-15

• K071406 — AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER2007-11-21
• K071920 — AUTOSUTURE ABSORBABLE TACK AND APPLICATOR2007-09-28
• K061288 — AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER2006-11-02
• K062850 — AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS2006-10-23
• K062326 — AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE2006-09-01

Injury

599

Malfunction

1,658

Total

2,257

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →