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FDA 510(k)

OPTIME, SINUSORB PGA

K-Number: K062366 · 2006-10-02

ApplicantPeters Surgical
Decision Date2006-10-02
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTIME, SINUSORB PGA is the device name listed in this FDA 510(k) record. The listed applicant is Peters Surgical. It received FDA 510(k) clearance on 2006-10-02 under 510(k) number K062366. 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 OPTIME, SINUSORB PGA?

OPTIME, SINUSORB PGA is a medical device that received FDA 510(k) clearance on 2006-10-02. The listed applicant is Peters Surgical. The 510(k) number is K062366.

When did OPTIME, SINUSORB PGA receive FDA 510(k) clearance?

OPTIME, SINUSORB PGA received FDA 510(k) clearance on 2006-10-02, under 510(k) number K062366.

Who is the listed applicant for OPTIME, SINUSORB PGA?

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 OPTIME, SINUSORB PGA?

The FDA product code for OPTIME, SINUSORB PGA is GAM.

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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 RK232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)K071281UNIRING - ANNULOPLASTY RING WITH SIZERSK060465PREMIOK060163CARDIOFLON, CARDIOXYLK052701COROLENE

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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

View on FDA Database →

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

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