Home / 510(k) Clearances / K801766

510(k) K801766

JACKSON-PRATT LARGE VOL. CLOSED WOUND by American Heyer Schulte — Product Code GCY

K801766 is an FDA 510(k) premarket notification submitted by American Heyer Schulte for the device "JACKSON-PRATT LARGE VOL. CLOSED WOUND". The FDA issued a decision of Substantially Equivalent on August 20, 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. American Heyer Schulte has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
July 28, 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 American Heyer Schulte

  • K840172 — VENTRAL WALL DEFECT REDUCT SILO (June 27, 1984)
  • K834593 — ONE-PIECE SHUNT (April 3, 1984)
  • K833502 — RADOVAN SUBCUTANEOUS TISSUE EXPANDER (February 3, 1984)
  • K833698 — AMER. V. MUELLER SURG. STAPLES ILA (January 25, 1984)
  • K833704 — AMER. V. MUELLER SURGICALSTAPLES-CARTR (December 29, 1983)
  • K832738 — HEYER-SCHULTE AFTERLOADING CATHETER (September 29, 1983)
  • K823790 — VENTRICULAR ACCESS SYSTEM (April 28, 1983)
  • K822096 — CHEMOTHERAPY INFUSION CATHETER (April 12, 1983)
  • K822032 — LARGE VOLUME CLOSED WOUND SUCTION DRAIN (August 16, 1982)
  • K820247 — EXTERNAL VENTRICULAR DRAINAGE SYS. (February 18, 1982)

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