Home / 510(k) Clearances / K800577

510(k) K800577

SNYDER HEMOVAC TM VENTED WOUND KIT by Snyder Laboratories, Inc. — Product Code GCY

K800577 is an FDA 510(k) premarket notification submitted by Snyder Laboratories, Inc. for the device "SNYDER HEMOVAC TM VENTED WOUND KIT". The FDA issued a decision of Substantially Equivalent on April 16, 1980. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Snyder Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1980
Date Received
March 14, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class
Class I
Regulation Number
878.4680
Review Panel
SU
Submission Type

Other clearances by Snyder Laboratories, Inc.

  • K843906 — SNYDER HEMOVAC WOUND DRAINAGE DEVICES (November 5, 1984)
  • K821321 — SNYDER DEBRIBEMENT SYSTEM LDP-1 (August 6, 1982)
  • K800861 — SNYDER HEMOVAC CHEST DRAINAGE SOLUTION (May 2, 1980)
  • K800578 — SURGIVAC TM (April 16, 1980)
  • K800543 — SNYDER HYSTERECTOMY Y TUBE KIT (April 16, 1980)
  • K800542 — 100 ML SNYDER HEMOVAC (April 2, 1980)
  • K790607 — GREENLINE IRRIGATION TRAYS (May 11, 1979)
  • K790606 — CATHETERS, GREENLINE SUCTION (April 23, 1979)
  • K790419 — YANKAUER & POODLE SUCTION INSTRUMENTS (April 23, 1979)
  • K790420 — SUCTION CONNECTING TUBING (April 23, 1979)

Other clearances for product code GCY

  • K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEM (October 1, 1997)
  • K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (June 3, 1997)
  • K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (December 12, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K930615 — AUTOVAC CLOSED WOUND SUCTION SYSTEM (February 22, 1994)
  • K933319 — BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTE (October 27, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)

FDA data resources