Home / 510(k) Clearances / K850037

510(k) K850037

CLOSED WOUND DRAIN by Consolidated Medical Equipment, Inc. — Product Code GCY

K850037 is an FDA 510(k) premarket notification submitted by Consolidated Medical Equipment, Inc. for the device "CLOSED WOUND DRAIN". The FDA issued a decision of Substantially Equivalent on Mar 19, 1985. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Consolidated Medical Equipment, Inc. has 14 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 19, 1985
Date Received
Jan 7, 1985
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
510(k) Exempt

Other clearances by Consolidated Medical Equipment, Inc.

  • K854040 — I.V. DRESSING (Jan 9, 1986)
  • K850132 — DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC (Apr 9, 1985)
  • K850130 — PRN ECG ELECTRODE (Apr 9, 1985)
  • K844942 — PLURA-GARD CHEST DRAINAGE SYSTEM (Mar 12, 1985)
  • K850131 — CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS (Mar 5, 1985)
  • K850311 — DISPOS. CONDUCTIVE ADHESIVE TENS PAD (Mar 5, 1985)
  • K850129 — MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN (Feb 28, 1985)
  • K850133 — VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. (Feb 28, 1985)
  • K844372 — HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE (Feb 21, 1985)
  • K844371 — HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE (Feb 20, 1985)

Other clearances for product code GCY

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

FDA data resources

Source: FDA 510(k) database entry for K850037. Report a data issue: hello@regdatalab.com.