Home / 510(k) Clearances / K881519

510(k) K881519

VAC-G (GUILLOTINE VITRECTOR) by B&B Medical Assoc., Inc. — Product Code HQE

K881519 is an FDA 510(k) premarket notification submitted by B&B Medical Assoc., Inc. for the device "VAC-G (GUILLOTINE VITRECTOR)". The FDA issued a decision of Substantially Equivalent on September 8, 1988. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. B&B Medical Assoc., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1988
Date Received
April 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by B&B Medical Assoc., Inc.

  • K881707 — INTROCULAR FLUID INJECTOR (October 21, 1988)
  • K881520 — VAC (OSCILLATING VITRECTOR) (September 7, 1988)
  • K881518 — INFUSION HANDLE (August 22, 1988)
  • K881517 — B & B I/A HANDPIECE (August 22, 1988)

Other clearances for product code HQE

  • K212763 — UniVit HE, UniVit UHS (August 10, 2022)
  • K170183 — Cetus system, Cetus probe (September 27, 2017)
  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K141065 — CONSTELLATION VISION SYSTEM (August 22, 2014)
  • K121675 — VERSAVIT (June 21, 2012)
  • K120170 — PROCARE PLUS VITRECTOMY SYSTEM (May 30, 2012)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
  • K030948 — VMATE MODEL VMM1000 (June 17, 2003)
  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)

FDA data resources