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FDA 510(k)

MMODIFICATION TO LAMINARIA

K-Number: K011512 · 2001-07-09

ApplicantA & A Medical, Inc.
Decision Date2001-07-09
Product CodeHDY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MMODIFICATION TO LAMINARIA is the device name listed in this FDA 510(k) record. The listed applicant is A & A Medical, Inc.. It received FDA 510(k) clearance on 2001-07-09 under 510(k) number K011512. The device is classified under product code HDY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MMODIFICATION TO LAMINARIA?

MMODIFICATION TO LAMINARIA is a medical device that received FDA 510(k) clearance on 2001-07-09. The listed applicant is A & A Medical, Inc.. The 510(k) number is K011512.

When did MMODIFICATION TO LAMINARIA receive FDA 510(k) clearance?

MMODIFICATION TO LAMINARIA received FDA 510(k) clearance on 2001-07-09, under 510(k) number K011512.

Who is the listed applicant for MMODIFICATION TO LAMINARIA?

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

What is the FDA product code for MMODIFICATION TO LAMINARIA?

The FDA product code for MMODIFICATION TO LAMINARIA is HDY.

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Other records listing A & A Medical, 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.

K013437SF SH CATHETER, MODEL R65-945K013491HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948K003949TACKER, MODEL R65-933K010510BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1K010789CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1K010056UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450

View all 23 devices →

Related Devices (Code: HDY)

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.

K040625ATAD ARD CATHETERAtad Developments , Ltd.K021012LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMQuality Medical Solusions, LLCK955072LAMINARIACti Corp., Ltd.K892220LAMINARIA TENTBerkeley MedevicesK881295LAMINARIA CUREXHarold W. Berger Co.K881312LAMINARIABusse Hospital Disposables, Inc.

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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