510(k) K061651
- Device
- FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
- Applicant
- APPLE MEDICAL CORP.
- 510(k) number
- K061651
- Product code
- HGI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-10-20
- Date received
- 2006-06-13
- Regulation
- 884.4120
- Classification name
- Electrocautery, Gynecologic (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN C PULFORD
- Address
- 28 Lord Rd., Unit 135 Marlboro MA US 01752 01752
FDA Registration Numbers#
- 3009903460
- 1720929
- 3015173212
- 1651252
- 1450908
- 2183744
- 1721686
- 8043396
- 3005350457
- 1836161
- 1060680
- 3004519921
- 9610612
- 2320762
- 3007728276
- 1043214
- 3015183635
- 1718873
- 1216677
- 3016245399
- 3005646850
- 1320894
- 3011120183
- 2246552
- 2916714
- 3032109
- 2511556
- 1054811
- 3003790304
- 1422634
- 1055236
- 3011989923
- 3007421149
- 1721676
- 1720747
- 9710649
- 3004491689
- 1061927
- 3006638824
- 1527736
- 1222773
- 3011050570
- 3013875599
- 8030607
- 3004636440
- 3010202439
- 8040510
- 2032112
- 1643817
- 2020550
- 3001592626
- 3011137372
- 1721194
- 1319639
- 2183715
- 9680721
- 3010361165
- 3013557562
- 1054241
- 3014279513
- 1928237
- 9613793
- 3010041511
- 3009103001
- 1650907
- 3005075853
Source Documents#
Other 510(k) Records For Product Code HGI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202915 | IRIS Thermocoagulator and Digital Colposcope | Liger Medical, LLC | 2021-04-23 |
| K152843 | Liger Medical HTU-110 | Liger Medical, LLC | 2016-06-24 |
| K130606 | FMWAND FERROMAGNETIC SURGICAL SYSTEM | Domain Surgical, Inc. | 2014-01-03 |
| K121881 | DOMAIN SURGICAL SYSTEM | Domain Surgical, Inc. | 2012-10-18 |
| K070877 | ENDOCERVICAL ELECTRODE # 2 | Modern Medical Equipment Mfg., Ltd. | 2007-07-27 |
| K022593 | THOMAS MEDICAL ELECTRODES | Thomas Medical, Inc. | 2002-11-01 |
| K003608 | SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY | Aesculap, Inc. | 2001-02-20 |
| K002042 | TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 | New England Medical Corp. | 2001-02-01 |
| K993527 | LOOP ELECTRODE, BALL ELECTRODE | Palm Medical USA, Inc. | 2000-07-06 |
| K993777 | DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES | R-Group Intl. | 2000-05-25 |
| K983840 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) | Wallach Surgical Devices, Inc. | 1999-05-20 |
| K982739 | GYNEX ELECTRODES | Gynex Corp. | 1999-03-12 |
| K974138 | ROCKET ELECTRODE | A & A Medical, Inc. | 1998-01-30 |
| K971986 | VALLEY FORGE BIPOLAR LOOP | Valley Forge Scientific Corp. | 1997-08-26 |
| K965245 | TBD | Utah Medical Products, Inc. | 1997-07-03 |
Legacy Summary#
summary
FDA Review#
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