510(k) K760868
- Device
- VEST RESTRAINT
- Applicant
- ORTHOPEDIC EQUIPMENT CO., INC.
- 510(k) number
- K760868
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-11-01
- Date received
- 1976-10-18
- Regulation
- 876.1075
- Classification name
- Instrument, Biopsy
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 1649518
- 3015967359
- 3005216725
- 3009423112
- 3007137598
- 3008492462
- 3015974593
- 1061927
- 1222780
- 3001592626
- 3002806603
- 9611481
- 3016678045
- 3017636737
- 2183613
- 2133810
- 3007664053
- 2246552
- 3015309643
- 3030733800
- 3012470322
- 1054811
- 3044399745
- 1000112137
- 3004636440
- 3013557562
- 3010082909
- 3015806723
- 2020394
- 1211566
- 2528981
- 3004962788
- 1018233
- 3030446844
- 3011642792
- 3022977243
- 3013041594
- 3010041511
- 3014032451
- 3015173212
- 1721983
- 3006786907
- 3004122598
- 1423537
- 3015225571
- 3004201275
- 3006788678
- 3007513241
- 9680001
- 3042940295
- 3005496266
- 3015142721
- 1721676
- 3010339638
- 2320767
- 1056129
- 3011137372
- 3003500271
- 3027260597
- 3030447506
- 3004111573
- 1223821
- 2953359
- 3015980719
- 3009337401
- 9680904
- 3010515547
- 3010966701
- 1222168
- 3015231789
- 3004749705
- 1921846
- 2029275
- 2649614
- 3012494290
- 9611680
- 3018094310
- 3013188547
- 3008496839
- 3014408997
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KNW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260517 | Automatic Core Biopsy Instrument | Zhejiang Curaway Medical Technology Co., Ltd. | 2026-08-28 |
| K262571 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2026-08-14 |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | 2026-08-12 |
| K260572 | Marrow Marxman | Medimetrix, LLC | 2026-08-04 |
| K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-12 |
| K260365 | Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char | Devicor Medical Products, Inc. | 2026-03-04 |
| K252795 | ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial | Argon Medical Devices, Inc. | 2026-02-23 |
| K252681 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2025-12-12 |
| K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | 2025-09-24 |
| K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | 2025-07-29 |
| K244018 | Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-07-22 |
| K243296 | Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. | 2025-07-11 |
| K250032 | Marquee™ Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular, Inc. | 2025-07-10 |
| K243886 | ExpressCore Biopsy Device | Inrad, Inc. | 2025-04-29 |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2025-04-24 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases