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FDA 510(k)

Novosyn Quick Absorbable Suture

K-Number: K170661 · 2017-06-08

ApplicantAesculap, Inc.
Decision Date2017-06-08
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Novosyn Quick Absorbable 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 2017-06-08 under 510(k) number K170661. 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 Novosyn Quick Absorbable Suture?

Novosyn Quick Absorbable Suture is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Aesculap, Inc.. The 510(k) number is K170661.

When did Novosyn Quick Absorbable Suture receive FDA 510(k) clearance?

Novosyn Quick Absorbable Suture received FDA 510(k) clearance on 2017-06-08, under 510(k) number K170661.

Who is the listed applicant for Novosyn Quick Absorbable 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 Novosyn Quick Absorbable Suture?

The FDA product code for Novosyn Quick Absorbable Suture is GAM.

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.

NCT05813236NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal SurgeryRECRUITINGNCT05433688Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass SurgeryCOMPLETEDNCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITINGNCT05281757Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® ComplexRECRUITINGNCT05296889Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® CervicalRECRUITINGNCT06024109Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total HysterectomyRECRUITING

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.

K242762Aesculap Aicon® Series Container SystemK242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetK223596SQ.line KERRISONK214041Aesculap AICON ContainerK211572Aesculap Slim Clip ApplierK203739ELAN 4 Electro Motor System

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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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