Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

POLYSORB SYNTHETIC ABSORBABLE SUTURE

K-Number: K895579 · 1990-07-05

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1990-07-05
Product CodeGAN
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

POLYSORB SYNTHETIC ABSORBABLE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1990-07-05 under 510(k) number K895579. The device is classified under product code GAN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the POLYSORB SYNTHETIC ABSORBABLE SUTURE?

POLYSORB SYNTHETIC ABSORBABLE SUTURE is a medical device that received FDA 510(k) clearance on 1990-07-05. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K895579.

When did POLYSORB SYNTHETIC ABSORBABLE SUTURE receive FDA 510(k) clearance?

POLYSORB SYNTHETIC ABSORBABLE SUTURE received FDA 510(k) clearance on 1990-07-05, under 510(k) number K895579.

Who is the listed applicant for POLYSORB SYNTHETIC ABSORBABLE SUTURE?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYSORB SYNTHETIC ABSORBABLE SUTURE?

The FDA product code for POLYSORB SYNTHETIC ABSORBABLE SUTURE is GAN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing United States Surgical, A Division of Tyco Healthc as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071406AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIERK071920AUTOSUTURE ABSORBABLE TACK AND APPLICATORK061288AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIERK062850AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERSK062326AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVEK061095AUTO SUTUR ENDO GIA STAPLERS

View all 218 devices →

Related Devices (Code: GAN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K003015SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBDSurgical Specialties CorpK964072MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDETHICON, Inc.K960653MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)ETHICON, Inc.K951231ORTHOPEDIC PACKSSterile Concepts, Inc.K920978ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYEDETHICON, Inc.K900198DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.American Cyanamid Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑