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FDA 510(k)

ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR

K-Number: K934636 · 1994-02-25

ApplicantAnnex Medical, Inc.
Decision Date1994-02-25
Product CodeFFL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Annex Medical, Inc.. It received FDA 510(k) clearance on 1994-02-25 under 510(k) number K934636. The device is classified under product code FFL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR?

ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR is a medical device that received FDA 510(k) clearance on 1994-02-25. The listed applicant is Annex Medical, Inc.. The 510(k) number is K934636.

When did ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR receive FDA 510(k) clearance?

ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR received FDA 510(k) clearance on 1994-02-25, under 510(k) number K934636.

Who is the listed applicant for ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR?

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

What is the FDA product code for ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR?

The FDA product code for ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR is FFL.

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Other records listing Annex 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.

K954377FORCEPS, GRASPING, FLEXIBLE ENDOSCOPICK952863FORCEPS, BIOPSY, NON-ELECTRICK951532METAL URETERAL BASKET STONE DISLODGERK951761METEL URETERAL BASKET STONE DISLODGERK934598GRASPING FORCEPS OR RETRIEVAL FORCEPSK934675METAL URETERAL BASKET STONE DISLODGER

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Related Devices (Code: FFL)

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.

K190492Peralta Stone Removal CatheterCalcula Technologies, Inc.K172299Accordion Piccolo Stone Management DeviceThs International, Inc. D/B/A Accordion MedicalK102887ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510Percutaneous Systems, Inc.K082803COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015Percutaneous Systems, Inc.K052048ACCORDIONPercutaneous Systems, IncorporatedK012581REPROCESSED STONE RETRIEVAL BASKETSSterilmed, 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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