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FDA 510(k)

ISPVAC TM

K-Number: K802973 · 1980-12-19

ApplicantInnovative Surgical Products, Inc.
Decision Date1980-12-19
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISPVAC TM is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Surgical Products, Inc.. It received FDA 510(k) clearance on 1980-12-19 under 510(k) number K802973. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISPVAC TM?

ISPVAC TM is a medical device that received FDA 510(k) clearance on 1980-12-19. The listed applicant is Innovative Surgical Products, Inc.. The 510(k) number is K802973.

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

ISPVAC TM received FDA 510(k) clearance on 1980-12-19, under 510(k) number K802973.

Who is the listed applicant for ISPVAC TM?

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

What is the FDA product code for ISPVAC TM?

The FDA product code for ISPVAC TM is GCY.

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Other records listing Innovative 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.

K843041HESLIN DISPOS. TUBING SETK840693DISPOSABLE SCLERAL GLOBE PLUGK840695PHACOEMULSIFICATION KITSK840694LENS INSERTION GLIDEK841072IRRIGATION, ASPIRATION TUBING SETSK832235DISPOSABLE VITRECTOMY HANDPIECE

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Related Devices (Code: GCY)

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.

K972703REDYROB-CLOSED WOUND DRAINAGE SYSTEMB.Braun Medical, Inc.K971036ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.K963839CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.K950754MACRO SUCTION TUBE MODEL NO 10061Dlp, Inc.K936223PRESSURE IRRIGATING SYSTEMLevel 1 Technologies, 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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