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FDA 510(k)

Rondek PGA Suture (Beige or Violet)

K-Number: K180625 · 2018-05-10

ApplicantRk Manufacturing Corporation
Decision Date2018-05-10
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Rondek PGA Suture (Beige or Violet) is the device name listed in this FDA 510(k) record. The listed applicant is Rk Manufacturing Corporation. It received FDA 510(k) clearance on 2018-05-10 under 510(k) number K180625. 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 Rondek PGA Suture (Beige or Violet)?

Rondek PGA Suture (Beige or Violet) is a medical device that received FDA 510(k) clearance on 2018-05-10. The listed applicant is Rk Manufacturing Corporation. The 510(k) number is K180625.

When did Rondek PGA Suture (Beige or Violet) receive FDA 510(k) clearance?

Rondek PGA Suture (Beige or Violet) received FDA 510(k) clearance on 2018-05-10, under 510(k) number K180625.

Who is the listed applicant for Rondek PGA Suture (Beige or Violet)?

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

What is the FDA product code for Rondek PGA Suture (Beige or Violet)?

The FDA product code for Rondek PGA Suture (Beige or Violet) is GAM.

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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