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510(k) K870577

E-Z LOOP by John F. Greer Co., Inc. — Product Code EXB

K870577 is an FDA 510(k) premarket notification submitted by John F. Greer Co., Inc. for the device "E-Z LOOP". The FDA issued a decision of Substantially Equivalent on April 17, 1987. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. John F. Greer Co., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1987
Date Received
February 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Ostomy
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
Submission Type

Other clearances by John F. Greer Co., Inc.

  • K870531 — EZ TAC FILTER (April 10, 1987)
  • K864190 — E-Z HOLD - #4060 (January 14, 1987)
  • K864189 — ULTRA-GEL - #4083 (December 4, 1986)
  • K864188 — E-Z HOLD WITH ADHESIVE BASE.-#4065 (December 4, 1986)

Other clearances for product code EXB

  • K252140 — Heylo™ System (October 6, 2025)
  • K181643 — SmartBag (SmartPouch) (November 16, 2018)
  • K140938 — OSTOM-I ALERT (October 10, 2014)
  • K922730 — LAKE OSTOMY CARE SET (December 30, 1993)
  • K882878 — ODOR-END EMERGENCY CLEAN UP POWDER (December 8, 1988)
  • K881636 — CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) (July 13, 1988)
  • K880306 — EMERGENCY-CLEAN UP(TM) ECP (May 20, 1988)
  • K872294 — COMBINATION NITE DRAINAGE UNIT (December 29, 1987)
  • K873929 — 'CATCH-IT' OR FECAL CONTAINMENT DEVICE (December 3, 1987)
  • K871526 — ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER (October 13, 1987)

FDA data resources