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510(k) K844829

ABDOMINAL PRESSURE CONTROL VALVE by L.A.S.E.R., Inc. — Product Code HHR

K844829 is an FDA 510(k) premarket notification submitted by L.A.S.E.R., Inc. for the device "ABDOMINAL PRESSURE CONTROL VALVE". The FDA issued a decision of Substantially Equivalent on May 1, 1985. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. L.A.S.E.R., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1985
Date Received
Dec 12, 1984
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 L.A.S.E.R., Inc.

  • K983965 — CO2 LASER COUPLER (Dec 22, 1998)
  • K950021 — REUSABLE TROCAR WITH SAFETY SLEEVE (Mar 31, 1995)
  • K940454 — GRASPING FORCEPS, PUNCHES, SCISSORS (Mar 25, 1994)
  • K931561 — TROCAR SLEEVE (Feb 7, 1994)
  • K933421 — ENDOSCOPIC INSTRUMENTS AND ACCESSDORIES (Nov 2, 1993)
  • K924844 — BULK TISSUE REMOVAL SYSTEM (Oct 8, 1993)
  • K932045 — DISPOSABLE INSUFFLATION TUBING (Sep 23, 1993)
  • K931092 — ENDOSCOPIC RETRACTOR (Apr 30, 1993)
  • K914197 — ALLOY SCALPEL HANDPIECES (Apr 10, 1992)
  • K904638 — TROCAR DISPOSABLE (Feb 21, 1991)

Other clearances for product code HHR

  • K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (Apr 27, 1989)
  • K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE (Aug 22, 1988)
  • K875314 — GL-35 COLPOSCOPIC LASER SYSTEM (Aug 5, 1988)
  • K874615 — LASER CANNISTER FILTER (Jun 23, 1988)
  • K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (Jun 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 (Mar 24, 1988)
  • K874837 — KTP/532 LASER FOR OB-GYN USE (Mar 14, 1988)
  • K875078 — HERACURE LS 500 (Feb 22, 1988)

FDA data resources