Product Code: KNC FDA class 2 21 CFR 884.4900

Table, Obstetric (And Accessories)

Obstetrics/Gynecology

An Obstetric Table with Accessories is a specialized examination and delivery table used in obstetrics and gynecology to position patients for labor, delivery, and gynecologic procedures, with adjustable components and accessories to support clinical care. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KNC and it is regulated under 21 CFR 884.4900 in the Obstetrics and Gynecology specialty.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: KNC
Device Class: FDA class 2
Regulation Number: 884.4900
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 26 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K001261	L720 EXAMINATION CHAIR	Jun 08, 2000	Substantially Equivalent	Luneau Gynecologie SA
K932035	NON-LINTING DELIVERY BLANKET	May 26, 1994	Substantially Equivalent	Amsco Sterile Recoveries, Inc.
K924420	MEDICAL DISPOSABLE BEDDING	Dec 10, 1993	Substantially Equivalent	Hill-Rom, Inc.
K914544	BD6000 THE OPTIMA & BD5000 BIRTHING BED	Nov 24, 1993	Substantially Equivalent	Lic Care, Inc.
K915779	AFFINITY BED MODEL 3600 SERIES	Feb 24, 1993	Substantially Equivalent	Hill-Rom, Inc.
K903973	GARDOSI BIRTHING CUSHION	Sep 27, 1990	Substantially Equivalent	Graphic Controls Corp.
K884868	OBSTETRICAL SAFETY SYSTEM	Mar 01, 1989	Substantially Equivalent	Buckman Co., Inc.
K870745	STRYKER MODEL 977 BIRTHING BED	Feb 27, 1987	Substantially Equivalent	Stryker Corp.
K864194	PALMER OBSTETRIC BRACE	Jan 14, 1987	Substantially Equivalent	Ad-Tech Medical Instrument Corp
K862931	MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358	Aug 07, 1986	Substantially Equivalent	Global Medical Prods, Inc.
K861030	LABOR-DELIVERY STRETCH/BED	Apr 23, 1986	Substantially Equivalent	Adel Medical , Ltd.
K852174	MERIVAARA OBSTETRIC CHAIR/BED MODEL 358	Sep 06, 1985	Substantially Equivalent	Daun International, Inc.
K852171	CAT. NO. S-5300-E BIRTHING BED	Aug 30, 1985	Substantially Equivalent	Shampaine/Wilson
K844183	PALMER OBSTETIC BRACE	Feb 04, 1985	Substantially Equivalent	Mic Medical Corp.
K842962	LORRAINE DSL LABOR & DELIVERY BED	Sep 25, 1984	Substantially Equivalent	Pulley-Kellam Co., Inc.
K833321	LABOR/DELIVERY/RECOVERY BED LDR-600	Nov 14, 1983	Substantially Equivalent	Adel Medical , Ltd.
K831998	BIRTHWELL BIRTHING SYSTEM	Sep 12, 1983	Substantially Equivalent	Qulab Co.
K831309	DELIVERY 4 TABLE	Jun 15, 1983	Substantially Equivalent	Amsco Co.
K830873	S & W MODEL ASO	May 13, 1983	Substantially Equivalent	S & W Enterprises, Inc.
K820175	O.N.A.T.	Jan 29, 1982	Substantially Equivalent	Latex Medical Devices, Inc.
K812141	LIC OBSTETRICAL TABLE	Aug 25, 1981	Substantially Equivalent	Lada Intl., Inc.
K811902	CENTURY BIRTHING CHAIR	Aug 25, 1981	Substantially Equivalent	Century Manufacturing Co.
K801622	ADEL MEDICAL BIRTHING BED, MOD. LD-400	Aug 14, 1980	Substantially Equivalent	Adel Medical , Ltd.
K792568	OBSTETRICAL BEDS	Jan 28, 1980	Substantially Equivalent	Ets Rene Marzet
K790950	S/A 7800 BIRTH SUPPORT CHAIR	Aug 03, 1979	Substantially Equivalent	Schlosser Alberti Co.
K770437	TABLE, EXAMINATION	Mar 23, 1977	Substantially Equivalent	I E Industries