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FDA 510(k)

LIGA-LOOP SUTURE APPLICATOR

K-Number: K993695 · 2000-04-13

ApplicantHysterx, Inc.
Decision Date2000-04-13
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGA-LOOP SUTURE APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hysterx, Inc.. It received FDA 510(k) clearance on 2000-04-13 under 510(k) number K993695. The device is classified under product code GAL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGA-LOOP SUTURE APPLICATOR?

LIGA-LOOP SUTURE APPLICATOR is a medical device that received FDA 510(k) clearance on 2000-04-13. The listed applicant is Hysterx, Inc.. The 510(k) number is K993695.

When did LIGA-LOOP SUTURE APPLICATOR receive FDA 510(k) clearance?

LIGA-LOOP SUTURE APPLICATOR received FDA 510(k) clearance on 2000-04-13, under 510(k) number K993695.

Who is the listed applicant for LIGA-LOOP SUTURE APPLICATOR?

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

What is the FDA product code for LIGA-LOOP SUTURE APPLICATOR?

The FDA product code for LIGA-LOOP SUTURE APPLICATOR is GAL.

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.

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Other records listing Hysterx, 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.

K000911MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057K992714MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010

Related Devices (Code: GAL)

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.

K072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTDemetech Corp.K042287UNIPLAIN & UNICHROMUnited Medical Industries Co. , Ltd.K042897AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGEEthicon Endo-Surgery, Inc.K030227SUTURTEK FASTCLOSE SUTURING DEVICESuturtek IncorporatedK020597SERRALGUTSerral, S.A. DE C.V.K021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICGramsmed, LLC

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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