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: K800874 · 1980-05-08

ApplicantPharmaseal Laboratories
Decision Date1980-05-08
Product CodeHHD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PELVIC EXAM TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaseal Laboratories. It received FDA 510(k) clearance on 1980-05-08 under 510(k) number K800874. The device is classified under product code HHD. 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 1980-05-08. The listed applicant is Pharmaseal Laboratories. The 510(k) number is K800874.

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

PELVIC EXAM TRAY received FDA 510(k) clearance on 1980-05-08, under 510(k) number K800874.

Who is the listed applicant for PELVIC EXAM TRAY?

The FDA 510(k) record lists Pharmaseal Laboratories 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 HHD.

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 Pharmaseal Laboratories 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.

K800737DEBRISAN (DEXTRANOMER) PASTEK801146SAMPLING KITK800362FLUID DISPENSING SYSTEMK760469CLEANSING AGENT, NEW WOUND (DEBRISSU)

Related Devices (Code: HHD)

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.

K071827ALWAYS MENSTRUAL PADSProcter & Gamble, Inc.K012629ALWAYS DUETSProcter & Gamble Co.K003843ENVIVE MINIFORMSProcter & Gamble Co.K993870UNSCENTED INTERLABIAL MENSTRUAL PADProcter & Gamble Co.K980395GLADRAGS COTTON MENSTRUAL PADKeepers!, Inc.K953470FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)Mediquip, 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.

↑