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FDA 510(k)

Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)

K-Number: K232372 · 2024-07-12

ApplicantPeters Surgical
Decision Date2024-07-12
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) is the device name listed in this FDA 510(k) record. The listed applicant is Peters Surgical. It received FDA 510(k) clearance on 2024-07-12 under 510(k) number K232372. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)?

Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) is a medical device that received FDA 510(k) clearance on 2024-07-12. The listed applicant is Peters Surgical. The 510(k) number is K232372.

When did Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) receive FDA 510(k) clearance?

Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) received FDA 510(k) clearance on 2024-07-12, under 510(k) number K232372.

Who is the listed applicant for Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)?

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

What is the FDA product code for Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)?

The FDA product code for Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) is GAM.

Other records listing Peters Surgical 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.

K233265Monotime and Optime R

Related Devices (Code: GAM)

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.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

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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