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510(k) K920985

SNOWDEN-PENCER IRRIGATION PUMP by Snowden-Pencer — Product Code HEI

K920985 is an FDA 510(k) premarket notification submitted by Snowden-Pencer for the device "SNOWDEN-PENCER IRRIGATION PUMP". The FDA issued a decision of Substantially Equivalent on June 9, 1992. The device falls under product code HEI (Monitor, Heart-Valve Movement, Fetal, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. Snowden-Pencer has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1992
Date Received
March 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Heart-Valve Movement, Fetal, Ultrasonic
Device Class
Class II
Regulation Number
884.2660
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)
  • K924148 — DIAMOND-SHARP(R) TROCARS (February 28, 1994)
  • K924149 — ENDO I/A PROBE (January 26, 1993)
  • 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 HEI

  • K012003 — DRG REACTION CHAMBER/SAFETY TIP (February 12, 2002)
  • K910982 — INNERVISION IRRIGATION PUMP (August 26, 1991)

FDA data resources