Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SAFEPASS STERILIZATION POUCH

K-Number: K973981 · 1998-01-29

ApplicantAdroit Medical Systems, Inc.
Decision Date1998-01-29
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFEPASS STERILIZATION POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Adroit Medical Systems, Inc.. It received FDA 510(k) clearance on 1998-01-29 under 510(k) number K973981. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFEPASS STERILIZATION POUCH?

SAFEPASS STERILIZATION POUCH is a medical device that received FDA 510(k) clearance on 1998-01-29. The listed applicant is Adroit Medical Systems, Inc.. The 510(k) number is K973981.

When did SAFEPASS STERILIZATION POUCH receive FDA 510(k) clearance?

SAFEPASS STERILIZATION POUCH received FDA 510(k) clearance on 1998-01-29, under 510(k) number K973981.

Who is the listed applicant for SAFEPASS STERILIZATION POUCH?

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

What is the FDA product code for SAFEPASS STERILIZATION POUCH?

The FDA product code for SAFEPASS STERILIZATION POUCH is KCT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Adroit Medical Systems, 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.

K073712SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100K970197HTP-1500 LOCALIZED HEAT THERAPY PUMPK962983STERILE SOFT-TEMPK921920SOFT-TEMPK921928SOFT-COVER

Related Devices (Code: KCT)

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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

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.

↑