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FDA 510(k)

LAPAROSTAT(TM)

K-Number: K913300 · 1992-04-02

ApplicantCook Ob/Gyn
Decision Date1992-04-02
Product CodeHAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAPAROSTAT(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ob/Gyn. It received FDA 510(k) clearance on 1992-04-02 under 510(k) number K913300. The device is classified under product code HAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSTAT(TM)?

LAPAROSTAT(TM) is a medical device that received FDA 510(k) clearance on 1992-04-02. The listed applicant is Cook Ob/Gyn. The 510(k) number is K913300.

When did LAPAROSTAT(TM) receive FDA 510(k) clearance?

LAPAROSTAT(TM) received FDA 510(k) clearance on 1992-04-02, under 510(k) number K913300.

Who is the listed applicant for LAPAROSTAT(TM)?

The FDA 510(k) record lists Cook Ob/Gyn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPAROSTAT(TM)?

The FDA product code for LAPAROSTAT(TM) is HAM.

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Other records listing Cook Ob/Gyn 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.

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Related Devices (Code: HAM)

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.

K153472Quiver Laparoscopic ExtendableItl Corporation Pty, Ltd.K000079NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777MNikomed U.S.A., Inc.K993306NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)Paladin Medical, Inc.K945861BERGEN 710 ESUBergen Mfg.K920100GSU HANDPIECE ADAPTERBeacon Laboratories, Inc.K911353EMC MODEL NO. STATOME 900Emc Industries

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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