Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Northgate Technologies, Inc. — Predicate Candidate Screening
55 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
384 days90th percentile
55clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202813 | URO-TOUCH 9 French Probe | Northgate Technologies, Inc. | 2021-06-14 | 263 | 0 |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | Northgate Technologies, Inc. | 2021-03-25 | 176 | 0 |
| K130368 | AUTOLITH TOUCH; URO TOUCH | Northgate Technologies, Inc. | 2013-11-15 | 274 | 2 |
| K120151 | NEBULAE I | Northgate Technologies, Inc. | 2012-08-17 | 212 | 0 |
| K041560 | FLO-ASSISTANT | Northgate Technologies, Inc. | 2004-09-28 | 110 | 0 |
| K033614 | MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 | Northgate Technologies, Inc. | 2004-07-29 | 255 | 0 |
| K022052 | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 | Northgate Technologies, Inc. | 2003-01-24 | 214 | 0 |
| K010053 | HUMI-FLOW, MODEL 6-850-00/ 01/02 | Northgate Technologies, Inc. | 2001-10-23 | 288 | 0 |
| K011928 | HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-4 | Northgate Technologies, Inc. | 2001-08-10 | 51 | 0 |
| K001325 | FLO ASSISTANT, MODEL 4-250-00 | Northgate Technologies, Inc. | 2000-08-18 | 114 | 0 |
| K993778 | HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 | Northgate Technologies, Inc. | 2000-01-06 | 59 | 0 |
| K992381 | CO2 GAS WARMER II, MODEL 6-800-00 | Northgate Technologies, Inc. | 1999-09-17 | 63 | 0 |
| K990341 | ELECTRO MECHANICAL LITHOTRIPTOR | Northgate Technologies, Inc. | 1999-07-14 | 161 | 0 |
| K983326 | OMNIFLATOR 7640 MODEL 7-640-00 | Northgate Technologies, Inc. | 1999-02-05 | 136 | 0 |
| K973447 | OMNIFLATOR 6630(6-630-00) | Northgate Technologies, Inc. | 1998-09-30 | 384 | 0 |
| K972675 | CO2 GAS WARMING UNIT (6-800-00) | Northgate Technologies, Inc. | 1998-09-30 | 441 | 0 |
| K973025 | FLUID CENTURION (4-100-00) | Northgate Technologies, Inc. | 1997-11-20 | 98 | 0 |
| K962271 | ELECTROSURGICAL ELECRTRODES | Northgate Technologies, Inc. | 1997-08-08 | 421 | 0 |
| K970717 | VAPOR-TECH SLED ELECTRODE | Northgate Technologies, Inc. | 1997-05-08 | 70 | 0 |
| K964196 | CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) | Northgate Technologies, Inc. | 1996-12-23 | 63 | 0 |
| K954710 | VAPOR-TECH ROLLER BALL ELECTRODE 24 FR. | Northgate Technologies, Inc. | 1996-04-24 | 195 | 0 |
| K955339 | HYDROLOGY 5000 | Northgate Technologies, Inc. | 1996-03-13 | 114 | 0 |
| K943361 | NORTHGATE FLOW ASSIST TUBING FOR UROLOGY | Northgate Technologies, Inc. | 1995-09-29 | 443 | 0 |
| K944571 | PULSE GUARD 3FR ELECTRODE | Northgate Technologies, Inc. | 1995-03-17 | 179 | 0 |
| K931065 | LAPAROVIEW | Northgate Technologies, Inc. | 1994-11-30 | 639 | 0 |
| K930912 | HYSTEROMED 100 | Northgate Technologies, Inc. | 1994-10-17 | 602 | 0 |
| K935862 | NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600 | Northgate Technologies, Inc. | 1994-08-19 | 259 | 0 |
| K925396 | PULSE GUARD ELECTRODE | Northgate Technologies, Inc. | 1993-07-30 | 277 | 0 |
| K923822 | AUTOLITH-IEHL | Northgate Technologies, Inc. | 1993-01-28 | 182 | 0 |
| K921451 | EVACUATOR, GASTRO-UROLOGY | Northgate Technologies, Inc. | 1992-10-28 | 216 | 1 |
| K921088 | EVACUATOR, GASTRO-UROLOGY | Northgate Technologies, Inc. | 1992-10-28 | 236 | 0 |
| K914517 | SD-200IEHL(TM) | Northgate Technologies, Inc. | 1992-06-30 | 265 | 0 |
| K915051 | MODIFICATION MODEL 7201 INSUFFLATOR | Northgate Technologies, Inc. | 1992-06-04 | 251 | 0 |
| K914861 | EVACUATION KIT #7-510-14 | Northgate Technologies, Inc. | 1992-01-27 | 90 | 0 |
| K914516 | 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | 1992-01-07 | 90 | 1 |
| K914515 | 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | 1992-01-07 | 90 | 0 |
| K914514 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | 1992-01-06 | 89 | 0 |
| K913955 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | 1991-11-29 | 85 | 0 |
| K914402 | RECIRCULATION KIT #7-510-18 | Northgate Technologies, Inc. | 1991-11-27 | 56 | 0 |
| K914403 | GENERAL USE KIT #7-510-20 | Northgate Technologies, Inc. | 1991-11-27 | 56 | 0 |
| K914401 | UNIVERSAL GENERAL USE KIT #7-510-16 | Northgate Technologies, Inc. | 1991-11-27 | 56 | 0 |
| K911179 | VERRES NEEDLES 5 & 6 INCHES | Northgate Technologies, Inc. | 1991-11-13 | 240 | 0 |
| K913992 | ASPIRATION/INJECTION NEEDLE | Northgate Technologies, Inc. | 1991-10-30 | 55 | 0 |
| K911364 | SPOON FORCEPS, 11MM | Northgate Technologies, Inc. | 1991-10-23 | 209 | 0 |
| K913991 | GRASPER, RATCHETED (5MM X 30CM) | Northgate Technologies, Inc. | 1991-10-04 | 29 | 0 |
| K911312 | SUCTION/IRRIGATION TUBE & TUBE WITH CHANNEL | Northgate Technologies, Inc. | 1991-09-19 | 178 | 0 |
| K911243 | CHOLANGIOCATH AND ATRAUMATIC BOWEL CLAMP | Northgate Technologies, Inc. | 1991-06-19 | 90 | 0 |
| K911365 | ELECTROCAUTERY CABLE, BOVIE(TM)/BANANA PLUGS | Northgate Technologies, Inc. | 1991-06-11 | 75 | 0 |
| K911316 | INSULATED HOOK SCISSORS/J & L HOOK KNIVES/SPATULA | Northgate Technologies, Inc. | 1991-04-29 | 34 | 0 |
| K905117 | ENDOSCOPE AND ACCESSORIES | Northgate Technologies, Inc. | 1991-04-25 | 163 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda