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FDA 510(k)

PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME

K-Number: K874975 · 1988-04-13

ApplicantAdvanced Surgical Products, Inc.
Decision Date1988-04-13
Product CodeHNY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Products, Inc.. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K874975. The device is classified under product code HNY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME?

PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is Advanced Surgical Products, Inc.. The 510(k) number is K874975.

When did PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME receive FDA 510(k) clearance?

PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME received FDA 510(k) clearance on 1988-04-13, under 510(k) number K874975.

Who is the listed applicant for PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME?

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

What is the FDA product code for PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME?

The FDA product code for PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME is HNY.

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Other records listing Advanced Surgical Products, 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.

K030926FAST THROW STAINLESS STEEL SURGICAL SUTUREK895800ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATORK896754I/A HANDPIECEK896305MULTI-USE I/A HANDPIECEK884557ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECEK884556DREYER CURVED ENDOILLUMINATOR

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Related Devices (Code: HNY)

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.

K961524STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORSSterilab, Inc.K880345CYSTOTOMES/KNIFESMyocure, Inc.K875001PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874983PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874997PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874993PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOMEAdvanced Surgical Products, 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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