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FDA 510(k)

VAC (OSCILLATING VITRECTOR)

K-Number: K881520 · 1988-09-07

ApplicantB&B Medical Assoc., Inc.
Decision Date1988-09-07
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VAC (OSCILLATING 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 1988-09-07 under 510(k) number K881520. 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 (OSCILLATING VITRECTOR)?

VAC (OSCILLATING VITRECTOR) is a medical device that received FDA 510(k) clearance on 1988-09-07. The listed applicant is B&B Medical Assoc., Inc.. The 510(k) number is K881520.

When did VAC (OSCILLATING VITRECTOR) receive FDA 510(k) clearance?

VAC (OSCILLATING VITRECTOR) received FDA 510(k) clearance on 1988-09-07, under 510(k) number K881520.

Who is the listed applicant for VAC (OSCILLATING 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 (OSCILLATING VITRECTOR)?

The FDA product code for VAC (OSCILLATING 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 INJECTORK881519VAC-G (GUILLOTINE 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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