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FDA 510(k)

CELL SWEEP

K-Number: K911327 · 1991-05-21

ApplicantReza S Mohajer, M.D. C/O Krass & Young
Decision Date1991-05-21
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CELL SWEEP is the device name listed in this FDA 510(k) record. The listed applicant is Reza S Mohajer, M.D. C/O Krass & Young. It received FDA 510(k) clearance on 1991-05-21 under 510(k) number K911327. 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 CELL SWEEP?

CELL SWEEP is a medical device that received FDA 510(k) clearance on 1991-05-21. The listed applicant is Reza S Mohajer, M.D. C/O Krass & Young. The 510(k) number is K911327.

When did CELL SWEEP receive FDA 510(k) clearance?

CELL SWEEP received FDA 510(k) clearance on 1991-05-21, under 510(k) number K911327.

Who is the listed applicant for CELL SWEEP?

The FDA 510(k) record lists Reza S Mohajer, M.D. C/O Krass & Young as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CELL SWEEP?

The FDA product code for CELL SWEEP is HHT.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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