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FDA 510(k)

VAC-G (GUILLOTINE VITRECTOR)

K-Number: K881519 · 1988-09-08

ApplicantB&B Medical Assoc., Inc.
Decision Date1988-09-08
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VAC-G (GUILLOTINE VITRECTOR) is the device name listed in this FDA 510(k) record. The listed applicant is B&B Medical Assoc., Inc.. It received FDA 510(k) clearance on 1988-09-08 under 510(k) number K881519. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAC-G (GUILLOTINE VITRECTOR)?

VAC-G (GUILLOTINE VITRECTOR) is a medical device that received FDA 510(k) clearance on 1988-09-08. The listed applicant is B&B Medical Assoc., Inc.. The 510(k) number is K881519.

When did VAC-G (GUILLOTINE VITRECTOR) receive FDA 510(k) clearance?

VAC-G (GUILLOTINE VITRECTOR) received FDA 510(k) clearance on 1988-09-08, under 510(k) number K881519.

Who is the listed applicant for VAC-G (GUILLOTINE VITRECTOR)?

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

What is the FDA product code for VAC-G (GUILLOTINE VITRECTOR)?

The FDA product code for VAC-G (GUILLOTINE VITRECTOR) is HQE.

Related Clinical Trials

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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Other records listing B&B Medical Assoc., 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.

K881707INTROCULAR FLUID INJECTORK881520VAC (OSCILLATING VITRECTOR)K881518INFUSION HANDLEK881517B & B I/A HANDPIECE

Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, 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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