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FDA 510(k)

SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW

K-Number: K053482 · 2005-12-27

ApplicantSutura, Inc.
Decision Date2005-12-27
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW is the device name listed in this FDA 510(k) record. The listed applicant is Sutura, Inc.. It received FDA 510(k) clearance on 2005-12-27 under 510(k) number K053482. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW?

SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW is a medical device that received FDA 510(k) clearance on 2005-12-27. The listed applicant is Sutura, Inc.. The 510(k) number is K053482.

When did SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW receive FDA 510(k) clearance?

SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW received FDA 510(k) clearance on 2005-12-27, under 510(k) number K053482.

Who is the listed applicant for SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW?

The FDA 510(k) record lists Sutura, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW?

The FDA product code for SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW is GAW.

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Other records listing Sutura, 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.

K062125SUPERSTITCH 5F, 12F, AND ELK020940SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00XK012865SUPERSTITCH VASCULAR SUTURING DEVICEK994087SUPERSTITCH

Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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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