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510(k) K924148

DIAMOND-SHARP(R) TROCARS by Snowden-Pencer — Product Code HFI

K924148 is an FDA 510(k) premarket notification submitted by Snowden-Pencer for the device "DIAMOND-SHARP(R) TROCARS". The FDA issued a decision of Substantially Equivalent on February 28, 1994. The device falls under product code HFI (Coagulator, Culdoscopic (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Snowden-Pencer has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1994
Date Received
August 18, 1992
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 Snowden-Pencer

  • K960400 — DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMO (March 12, 1996)
  • K930666 — REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY (May 19, 1994)
  • K930667 — REUSABLE LAPAROSCOPIC INSTRUMENTS (May 16, 1994)
  • K924149 — ENDO I/A PROBE (January 26, 1993)
  • K920985 — SNOWDEN-PENCER IRRIGATION PUMP (June 9, 1992)
  • K920986 — SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700 (June 4, 1992)
  • K913979 — ENDO I/A Y SET (November 27, 1991)
  • K913835 — SNOWDEN-PENCER INSUFFLATOR TUBING SET (November 7, 1991)
  • K861372 — ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY (June 19, 1986)

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)
  • K925114 — LAPAROSCOPIC INSTRUMENTS (February 28, 1994)
  • K930571 — REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING (February 1, 1994)
  • K844053 — CANON 60 DEGREE FUNDUS CAMERA CF-60S (December 19, 1984)

FDA data resources