510(k) K781101
- Device
- ELECTROSURGICAL UNIT 75
- Applicant
- RITTER CO.
- 510(k) number
- K781101
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-07-17
- Date received
- 1978-07-03
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010187826
- 1418975
- 8010312
- 3048053025
- 3014925413
- 3012470322
- 3030446844
- 1718873
- 3015225571
- 3007842664
- 3010594949
- 3005695724
- 3014262693
- 3010131466
- 3015540957
- 3012818475
- 3007648309
- 1526534
- 3010400367
- 1000122786
- 3001124136
- 3004464325
- 1030489
- 3013886523
- 9611503
- 2183870
- 3008868758
- 3030645016
- 1030451
- 8010177
- 3002807090
- 3043532708
- 2433012
- 3008816935
- 3008791915
- 3016555232
- 3016727307
- 3043226252
- 1418479
- 2219920
- 3048141561
- 9617070
- 3011307265
- 3017405993
- 3016050940
- 3014579024
- 3015453963
- 2182318
- 1220477
- 3013376016
- 2182269
- 3004598644
- 3004111573
- 3012497308
- 3012447612
- 8043746
- 3009513193
- 2182799
- 2028523
- 3011782009
- 3015153469
- 3016087306
- 3013505983
- 3016076698
- 3030153385
- 1828288
- 3007456622
- 3011559089
- 2648666
- 1223422
- 1724474
- 3029895042
- 2087572
- 3004483538
- 2133810
- 8010418
- 1421879
- 1825146
- 3022320321
Source Documents#
510(k) summary PDF not indicated by FDA
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| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | 2026-06-16 |
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | 2026-06-09 |
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 |
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Legacy Summary#
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FDA Review#
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