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510(k) K880650

HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS by Baxter Healthcare Corp — Product Code GCY

K880650 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS". The FDA issued a decision of Substantially Equivalent on Feb 24, 1988. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 24, 1988
Date Received
Feb 17, 1988
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

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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 K880650. Report a data issue: hello@regdatalab.com.