FDA 510(k)

DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH

K-Number: K942879 · 1994-07-19

Decision Date1994-07-19

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1994-07-19 under 510(k) number K942879. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH?

DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH is a medical device that received FDA 510(k) clearance on 1994-07-19. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K942879.

When did DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH receive FDA 510(k) clearance?

DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH received FDA 510(k) clearance on 1994-07-19, under 510(k) number K942879.

Who is the listed applicant for DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH?

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

What is the FDA product code for DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH?

The FDA product code for DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH is GCJ.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Deroyal Industries, Inc. as applicant

K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory K230233Prospera Spectruum Negative Pressure Wound Therapy System K200631DeRoyal Temperature Monitoring Probe K200757Foley Catheter with Temperature Sensor K200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable K193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French

View all 90 devices →

Related Devices (Code: GCJ)

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical Impact K261614LED LCD Monitor (OEV-271H)Lg Electronics.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.