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FDA 510(k)

STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234

K-Number: K001649 · 2000-06-23

ApplicantSteritec Products, Inc.
Decision Date2000-06-23
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 is the device name listed in this FDA 510(k) record. The listed applicant is Steritec Products, Inc.. It received FDA 510(k) clearance on 2000-06-23 under 510(k) number K001649. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234?

STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 is a medical device that received FDA 510(k) clearance on 2000-06-23. The listed applicant is Steritec Products, Inc.. The 510(k) number is K001649.

When did STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 receive FDA 510(k) clearance?

STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 received FDA 510(k) clearance on 2000-06-23, under 510(k) number K001649.

Who is the listed applicant for STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234?

The FDA 510(k) record lists Steritec Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234?

The FDA product code for STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 is JOJ.

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Other records listing Steritec Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K083650EMU-GRAPH 4 EMULATOR, MODEL CI 144K080136INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105K052516STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137K040901STERITEC EMU-GRAPH, MODEL NO. CI 131/USK024293BOWIE-DICK MINI PAK, MODEL BD 115K012732INTEGRAPH FLASH, MODEL CI 110

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Related Devices (Code: JOJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLCK260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer GroupK251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA Test StripsSerim ResearchK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS CorporationK243876VERIFY STEAM Integrating IndicatorSTERIS Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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