Atlas FDA

ENDOMETRIAL SAMPLER

FDA 510(k) clearance K872908 · decided 1987-10-20

Clearance details

K-number
K872908
Device name
ENDOMETRIAL SAMPLER
Applicant
Zinnanti Surgical Instruments, Inc.
Decision
Substantially Equivalent
Date received
1987-07-24
Decision date
1987-10-20
Days to decision
88 days
Clearance type
Traditional
Product code
HHK
Device class
2
Regulation number
884.1175
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Woodland Hills, CA, 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
Uterine Aspiration Set (K251882)Gcmedica Enterprise Ltd.(Wuxi)2025-10-16
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) (K240434)Li Medical Corporation , Ltd.2024-09-25
CrossGlide ETS Plus (K201952)Crossbay Medical2020-08-05
CrossBay Endometrial Tissue Sampler (ETS) (K192534)Crossbay Medical2020-03-25
DISPOSABLE ENDOMETRIAL SUCTION CURETTE (K102847)Jiangsu Suyun Medical Materials Co., Ltd.2011-04-14
THE PANPAC SUCTION CURETTE (K092982)Panpac Medical Corporation2010-07-26
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (K051294)Femspec LLC2005-12-21
ENDOMETRIAL SAMPLING SYRINGE (K040189)Rocket Medical Plc2004-10-04
MAS WITH OR WITHOUT SYRINGE (K021876)Marina Medical Instruments, Inc.2003-04-08
CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (K020628)Bioteque America, Inc.2002-05-24
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (K001555)Sims Portex , Ltd.2000-08-02
PIPET CURET (K001545)Milex Products, Inc.2000-06-15

Recalls involving this device

No recalls on record reference this clearance.