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510(k) K960400

DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) by Snowden-Pencer — Product Code FBM

K960400 is an FDA 510(k) premarket notification submitted by Snowden-Pencer for the device "DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)". The FDA issued a decision of Substantially Equivalent on March 12, 1996. The device falls under product code FBM (Cannula And Trocar, Suprapubic, Non-Disposable), a Class I device regulated under 21 CFR 876.5090. Snowden-Pencer has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1996
Date Received
January 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula And Trocar, Suprapubic, Non-Disposable
Device Class
Class I
Regulation Number
876.5090
Review Panel
GU
Submission Type

Other clearances by Snowden-Pencer

  • K930666 — REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY (May 19, 1994)
  • K930667 — REUSABLE LAPAROSCOPIC INSTRUMENTS (May 16, 1994)
  • K924148 — DIAMOND-SHARP(R) TROCARS (February 28, 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 FBM

  • K932021 — ENTREE CANNULA FASCIA ANCHORS (January 11, 1994)
  • K911813 — ENTREE CANNULA (July 19, 1991)
  • K900961 — GS-4100 REDUCER SLEEVE, 5MM TO 3MM (April 18, 1990)
  • K900963 — GS-4350 TROCAR ONLY, 5.5MM (April 18, 1990)
  • K900964 — CANNULA AND TROCAR, 11MM (April 18, 1990)
  • K900965 — GS-4550 TROCAR ONLY, 11MM (April 18, 1990)
  • K900962 — GS-4300 CANNULA AND TROCAR, 5.5MM (April 18, 1990)
  • K900955 — GS-4000 REDUCER SLEEVE, 11MM TO 5MM (April 18, 1990)

FDA data resources