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FDA 510(k)

Monotime and Optime R

K-Number: K233265 · 2024-10-11

ApplicantPeters Surgical
Decision Date2024-10-11
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Monotime and Optime R is the device name listed in this FDA 510(k) record. The listed applicant is Peters Surgical. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K233265. 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 Monotime and Optime R?

Monotime and Optime R is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Peters Surgical. The 510(k) number is K233265.

When did Monotime and Optime R receive FDA 510(k) clearance?

Monotime and Optime R received FDA 510(k) clearance on 2024-10-11, under 510(k) number K233265.

Who is the listed applicant for Monotime and Optime R?

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 Monotime and Optime R?

The FDA product code for Monotime and Optime R 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.

K232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)

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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