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FDA 510(k)

ACCELLON CERVICAL BIOSAMPLER

K-Number: K911432 · 1993-09-03

ApplicantMedscand AB
Decision Date1993-09-03
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ACCELLON CERVICAL BIOSAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Medscand AB. It received FDA 510(k) clearance on 1993-09-03 under 510(k) number K911432. 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 ACCELLON CERVICAL BIOSAMPLER?

ACCELLON CERVICAL BIOSAMPLER is a medical device that received FDA 510(k) clearance on 1993-09-03. The listed applicant is Medscand AB. The 510(k) number is K911432.

When did ACCELLON CERVICAL BIOSAMPLER receive FDA 510(k) clearance?

ACCELLON CERVICAL BIOSAMPLER received FDA 510(k) clearance on 1993-09-03, under 510(k) number K911432.

Who is the listed applicant for ACCELLON CERVICAL BIOSAMPLER?

The FDA 510(k) record lists Medscand AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCELLON CERVICAL BIOSAMPLER?

The FDA product code for ACCELLON CERVICAL BIOSAMPLER 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.

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Other records listing Medscand AB 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.

K984211MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303

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.

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