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510(k) K864378

CO2 LASER MICROMANIPULATOR by Transamerican Technologies Intl. — Product Code HHR

K864378 is an FDA 510(k) premarket notification submitted by Transamerican Technologies Intl. for the device "CO2 LASER MICROMANIPULATOR". The FDA issued a decision of Substantially Equivalent on March 5, 1987. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Transamerican Technologies Intl. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1987
Date Received
November 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Surgical, Gynecologic
Device Class
Class II
Regulation Number
884.4550
Review Panel
OB
Submission Type

Other clearances by Transamerican Technologies Intl.

  • K971677 — ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD (August 20, 1997)
  • K963193 — ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 (November 13, 1996)
  • K934398 — ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE (February 14, 1994)

Other clearances for product code HHR

  • K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (April 27, 1989)
  • K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE (August 22, 1988)
  • K875314 — GL-35 COLPOSCOPIC LASER SYSTEM (August 5, 1988)
  • K874615 — LASER CANNISTER FILTER (June 23, 1988)
  • K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (June 1, 1988)
  • K880930 — MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE (May 31, 1988)
  • K880991 — LASER OPTICAL CATHETER SYSTEM (May 25, 1988)
  • K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (March 24, 1988)
  • K874837 — KTP/532 LASER FOR OB-GYN USE (March 14, 1988)
  • K875078 — HERACURE LS 500 (February 22, 1988)

FDA data resources