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FDA 510(k)

FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES

K-Number: K092533 · 2009-09-15

Decision Date2009-09-15
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES is the device name listed in this FDA 510(k) record. The listed applicant is Beere Precision Medical Instruments, Kmedic, Telef. It received FDA 510(k) clearance on 2009-09-15 under 510(k) number K092533. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES?

FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES is a medical device that received FDA 510(k) clearance on 2009-09-15. The listed applicant is Beere Precision Medical Instruments, Kmedic, Telef. The 510(k) number is K092533.

When did FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES receive FDA 510(k) clearance?

FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES received FDA 510(k) clearance on 2009-09-15, under 510(k) number K092533.

Who is the listed applicant for FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES?

The FDA 510(k) record lists Beere Precision Medical Instruments, Kmedic, Telef as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES?

The FDA product code for FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES is GAT.

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.

Related Devices (Code: GAT)

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.

Official Source

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

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