510(k) K121868
- Device
- MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)
- Applicant
- HOLOGIC, INC.
- 510(k) number
- K121868
- Product code
- HIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-07-19
- Date received
- 2012-06-26
- Regulation
- 884.1690
- Classification name
- Hysteroscope (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SARAH FAIRFIELD
- Address
- 250 Campus Dr. Malborough MA US 01752 01752
FDA Registration Numbers#
- 3004784537
- 3013557562
- 8043903
- 9710641
- 3027454635
- 3012322232
- 1319639
- 9710457
- 3009420598
- 1220477
- 3043236281
- 3035387162
- 1216677
- 3014407293
- 3010132111
- 3014461810
- 8010047
- 2953359
- 3009746061
- 3011050570
- 3029929134
- 3011543740
- 3025482817
- 3024021261
- 3010399422
- 3003724334
- 3042158861
- 3011459664
- 1222313
- 1056128
- 9610773
- 9612074
- 8010877
- 3007699067
- 3015972753
- 9611612
- 3035781529
- 3014615697
- 9680515
- 3015512350
- 2954783
- 3007829657
- 2245304
- 3011986317
- 3023365313
- 9614434
- 3014342096
- 9610595
- 3021246306
- 3013944123
- 3030153385
- 9680718
- 3003990090
- 3015142721
- 1650907
- 3030733800
- 3015976667
- 8010510
- 1221485
- 1223490
- 3007156625
- 9681753
- 2085947
- 3012494290
- 3010202439
- 3008386005
- 9515015
- 3015042209
- 3006330030
- 9610617
- 3021023673
- 3043226252
- 2244478
- 8010349
- 3035710892
- 3007200016
- 3007113251
- 3002807310
- 3011011193
- 3002808148
Source Documents#
Other 510(k) Records For Product Code HIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254252 | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) | Karl Storz SE & CO. KG | 2026-09-25 |
| K261102 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 2026-09-18 |
| K254294 | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30) | Zhejiang Geyi Medical Instrument Co., Ltd. | 2026-09-08 |
| K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) | Axora Medical, Inc. | 2026-08-18 |
| K253020 | Strauss Surgical Resection Instruments | American Medical Endoscopy, Inc. | 2026-06-04 |
| K254050 | Manual Tissue Removal Device | Suzhou AcuVu Medical Technology Co., Ltd. | 2026-05-15 |
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23) | Shanghai AnQing Medical Instrument Co., Ltd. | 2026-02-26 |
| K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) | Jiangsu Jiyuan Medical Technology Co., Ltd. | 2025-12-18 |
| K252012 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | 2025-07-18 |
| K243382 | RZ Resectoscope System | Rz Medizintechnik GmbH | 2025-06-03 |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) | MacroLux Medical Technology Co., Ltd. | 2024-08-16 |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-08-02 |
| K240401 | ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) | Origyn Medical Technology (Hangzhou) Co., Ltd. | 2024-07-26 |
| K231260 | HTx Disposable Hysteroscope System | Suzhou AcuVu Medical Technology Co., Ltd. | 2024-03-05 |
| K232003 | Endoscopic Video Image Processor, Single-Use Video Hysteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-02-12 |
Legacy Summary#
summary
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