Atlas FDA

Flexipet Denuding Pipette, Flexipet Manipulation Pipette

FDA 510(k) clearance K150748 · decided 2015-12-18

Clearance details

K-number
K150748
Device name
Flexipet Denuding Pipette, Flexipet Manipulation Pipette
Applicant
Cook Incorporated
Decision
Substantially Equivalent
Date received
2015-03-23
Decision date
2015-12-18
Days to decision
270 days
Clearance type
Traditional
Product code
MQH
Device class
2
Regulation number
884.6130
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Bloomington, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Denudation Pipettes (K250838)Guangzhou Pinzhi Medical Device Co., Ltd.2025-07-03
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LifeGlobal Micro Tips (K152581)Life Global Group, LLC2016-04-11
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BIOPSY PIPETTES (K133257)Research Instruments , Ltd.2014-05-16
INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA (K102480)Jieying Laboratory, Inc.2011-04-19
BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES (K092554)Sunlight Medical, Inc.2010-04-30
INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES (K072600)Sunlight Medical, Inc.2008-05-19
THE STRIPPER PGD (K041435)Mid-Atlantic Diagnostics, Inc.2004-09-29
CRYOTIP (K041562)Irvine Scientific Sales Co., Inc.2004-08-09
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) (K033904)Cook Urological, Inc.2004-01-16

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005)Cook Incorporated2009-04-02
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006)Cook Incorporated2009-03-05
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004)Cook Incorporated2008-05-08
COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002)Cook Incorporated2000-06-12
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001)Cook Incorporated1998-07-08
COOK CHORIONIC VILLUS SAMPLING SET (P900007)Cook Incorporated1994-09-30