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FDA 510(k)

Non Absorbable Surgical Nylon Suture

K-Number: K212603 · 2021-12-22

ApplicantShandong Haidike Medical Product Co., Ltd.
Decision Date2021-12-22
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Non Absorbable Surgical Nylon Suture is a medical device manufactured by Shandong Haidike Medical Product Co., Ltd.. It received FDA 510(k) clearance on 2021-12-22 under approval number K212603. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Non Absorbable Surgical Nylon Suture?

Non Absorbable Surgical Nylon Suture is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Shandong Haidike Medical Product Co., Ltd.. The 510(k) number is K212603.

When was Non Absorbable Surgical Nylon Suture approved by the FDA?

Non Absorbable Surgical Nylon Suture received FDA 510(k) clearance on 2021-12-22, under approval number K212603.

What company makes Non Absorbable Surgical Nylon Suture?

Non Absorbable Surgical Nylon Suture is manufactured by Shandong Haidike Medical Product Co., Ltd..

What is the FDA product code for Non Absorbable Surgical Nylon Suture?

The FDA product code for Non Absorbable Surgical Nylon Suture is GAR.

Related Clinical Trials

NCT06511414 Effect of Duramesh™ on Hernia Formation After Ileostomy Closure ACTIVE_NOT_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07574086 Stratafix vs. PDS (Fascial Closure RCT) NOT_YET_RECRUITING NCT05261425 Suture Closure Trial COMPLETED NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING NCT07498361 Comparative Analysis of fast-and Slow-absorbable Poly(Lactose-co-glycolide) Sutures in Oral Surgery: a Randomized Controlled Trial. RECRUITING

Other Devices by Shandong Haidike Medical Product Co., Ltd.

K232355Non absorbable Surgical Silk Suture

Related Devices (Code: GAR)

K151165Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc. K161633REXLON, REXSILSm Eng Co., Ltd. K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd. K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit Sutures K220980Tissue Approximation System (TAS)Tas Medical, Inc.

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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