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510(k) K930571

REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING by Numed Technologies, Inc. — Product Code HFI

K930571 is an FDA 510(k) premarket notification submitted by Numed Technologies, Inc. for the device "REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING". The FDA issued a decision of Substantially Equivalent on February 1, 1994. The device falls under product code HFI (Coagulator, Culdoscopic (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Numed Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1994
Date Received
February 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator, Culdoscopic (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type

Other clearances by Numed Technologies, Inc.

  • K922248 — MALLAWANY ATRAUMATIC TISSUE FORCEPS (February 17, 1994)
  • K931501 — NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST. (January 11, 1994)
  • K923126 — MALLAWANY TISSUE GRASPING FORCEPS (October 8, 1993)
  • K923055 — OPERATING SCISSORS FOR LAPAROSCOPIC SURGERIES (November 23, 1992)

Other clearances for product code HFI

  • K151567 — ENDOPLUS hand-held laparoscopic instruments (December 23, 2015)
  • K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K936026 — COOK LAPAROSCOPIC MINI RETRACTOR SET (March 11, 1994)
  • K924148 — DIAMOND-SHARP(R) TROCARS (February 28, 1994)
  • K925114 — LAPAROSCOPIC INSTRUMENTS (February 28, 1994)
  • K844053 — CANON 60 DEGREE FUNDUS CAMERA CF-60S (December 19, 1984)

FDA data resources