Home / 510(k) Clearances / K934874

510(k) K934874

STERIGAGE EO 100% by Pymah Corp. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1995
Date Received
October 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

Other clearances by Pymah Corp.

  • K952995 — ATI ETHYLENE OXIDE STERILIZATION INDICATOR (February 22, 1996)
  • K952408 — ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION (July 6, 1995)
  • K951063 — ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION (May 10, 1995)
  • K943081 — TRIMLINE 2000 (January 27, 1995)
  • K925745 — ATI(R) DISP BIOLOGICAL-PLUS TEST PACK (February 1, 1994)
  • K925496 — ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK (February 1, 1994)
  • K934180 — SLIMLINE 3000 (November 24, 1993)
  • K924681 — GLUTARALDEHYDE MONITORS (November 17, 1993)
  • K925744 — TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF (July 30, 1993)
  • K930604 — BALANCED(TM) NYLON BLADDER (April 30, 1993)

Other clearances for product code JOJ

  • K260181 — LF Process Indicator Tape for Steam Sterilization (February 20, 2026)
  • K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeS (December 23, 2025)
  • K251035 — DISINTEK™ PA Test Strips (June 3, 2025)
  • K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (May 2, 2025)
  • K243876 — VERIFY STEAM Integrating Indicator (April 25, 2025)
  • K250172 — Green Card Bowie-Dick Test (BD115) (February 20, 2025)
  • K242860 — Type 5 Integrating Indicator for Steam (CSPN-15) (January 17, 2025)
  • K241036 — Autoclave Indicator Tape; EO Indicator Tape (December 17, 2024)
  • K243475 — Chemical Indicator for enspire CLCSPS (LCC015) (December 4, 2024)
  • K242795 — Getinge Assured MI Steam Migrating Integrator (October 15, 2024)