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FDA 510(k)

PREMICRON NONABSORBABLE PET SURGICAL SUTURE

K-Number: K012201 · 2001-09-19

Decision Date2001-09-19
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PREMICRON NONABSORBABLE PET SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2001-09-19 under 510(k) number K012201. 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 PREMICRON NONABSORBABLE PET SURGICAL SUTURE?

PREMICRON NONABSORBABLE PET SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Aesculap, Inc.. The 510(k) number is K012201.

When did PREMICRON NONABSORBABLE PET SURGICAL SUTURE receive FDA 510(k) clearance?

PREMICRON NONABSORBABLE PET SURGICAL SUTURE received FDA 510(k) clearance on 2001-09-19, under 510(k) number K012201.

Who is the listed applicant for PREMICRON NONABSORBABLE PET SURGICAL SUTURE?

The FDA 510(k) record lists Aesculap, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREMICRON NONABSORBABLE PET SURGICAL SUTURE?

The FDA product code for PREMICRON NONABSORBABLE PET SURGICAL SUTURE 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.

Other records listing Aesculap, Inc. 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.

View all 195 devices →

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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