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)

PELVIC EXAM TRAY

K-Number: K934732 · 1994-12-30

ApplicantMedcare Custom Packaging, Inc.
Decision Date1994-12-30
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PELVIC EXAM TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Custom Packaging, Inc.. It received FDA 510(k) clearance on 1994-12-30 under 510(k) number K934732. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PELVIC EXAM TRAY?

PELVIC EXAM TRAY is a medical device that received FDA 510(k) clearance on 1994-12-30. The listed applicant is Medcare Custom Packaging, Inc.. The 510(k) number is K934732.

When did PELVIC EXAM TRAY receive FDA 510(k) clearance?

PELVIC EXAM TRAY received FDA 510(k) clearance on 1994-12-30, under 510(k) number K934732.

Who is the listed applicant for PELVIC EXAM TRAY?

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

What is the FDA product code for PELVIC EXAM TRAY?

The FDA product code for PELVIC EXAM TRAY is HHT.

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 Medcare Custom Packaging, 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.

K954869MEDCARE YANKAUER SUCTION DEVICEK954442STERILE ISOTONIC SALINE & STERILE WATERK952759TOWEL PACKK950390URETHRAL CATHETERIZATION TRAYK943661STERILE PHYSIOLOGICAL SALINE/STERILE WATERK951149SINGLE USE INSTRUMENT TRAY

View all 11 devices →

Related Devices (Code: HHT)

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.

K182049exCellerator Cervical Collection DeviceExcell Company, LLCK153128Kolplast Cervical Sample Collection KitKolplast CI SAK111681HISTOBRUSHPuritan Medical Products Company, LLCK083012PAPCONEOtto Bock Pur Life Science GmbHK081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYBio Nuclear Diagnostics, Inc.K072381SOFTPAP CERVICAL CELL COLLECTORCytocore, 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.

↑