Anesthesiology
Review Panel
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- ChemistryReview Panel
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- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- FADStent, Ureteral2Product Code
- EXXProbe, Rectal, Non-Powered1Product Code
- EYDStirrups1Product Code
- EYHTable, Cysto, Non-Electrical1Product Code
- EYSRibdam1Product Code
- EZOUrethrotome2Product Code
- EZPRod, Colostomy2Product Code
- FARUnit, Electrosurgical2Product Code
- FASElectrode, Electrosurgical, Active, Urological2Product Code
- FBJCord, Electric For Transurethral Surgical Instrument2Product Code
- FBSSound, Metal, Interconnected1Product Code
- FCHTray, Biopsy, Without Biopsy Instruments1Product Code
- FCSLight, Catheter, Fiberoptic, Glass, Ureteral2Product Code
- FDBPlate, Patient2Product Code
- FDGRetractor, Fiberoptic1Product Code
- FDISnare, Flexible2Product Code
- FDJSnare, Rigid Self-Opening2Product Code
- FDLWristlet, Patient Return2Product Code
- FEHElectrode, Flexible Suction Coagulator2Product Code
- FEOLithotriptor, Ultrasonic2Product Code
- FFDEvacuator, Bladder, Manually Operated1Product Code
- FFESystem, Water Jet Catheter, Renal2Product Code
- FFISystem, Alarm, Electrosurgical2Product Code
- FFKLithotriptor, Electro-Hydraulic2Product Code
- FFLDislodger, Stone, Basket, Ureteral, Metal2Product Code
- FFNClamp, Non-Electrical1Product Code
- FFORetractor, Self-Retaining1Product Code
- FFQSpeculum, Rectal1Product Code
- FFRDevice, Locking, For Intestinal Clamp1Product Code
- FGKTripsor, Stone, Bladder2Product Code
- FGMProbe And Director, Gastro-Urology1Product Code
- FGNRetractor, Non-Self-Retaining1Product Code
- FGODislodger, Stone, Flexible2Product Code
- FGWClamp, Electrical2Product Code
- FGXSnare, Non-Electrical1Product Code
- FHBHook, Gastro-Urology1Product Code
- FHCAdaptor To The Cord, For Transurethral Surgical Instrument2Product Code
- FHFSystem, Evacuator, Fluid2Product Code
- FHHCrusher, Spur, Colostomy1Product Code
- FHIRing, Laparotomy1Product Code
- FHKSpreader, Bladder Neck1Product Code
- FHLScoop1Product Code
- FHNLigator, Hemorrhoidal2Product Code
- FHQHolder, Needle, Gastroenterologic1Product Code
- FHYJelly, Contact, For Transurethral Surgical Instrument2Product Code
- FHZDesiccator, Transurethral2Product Code
- FKKClamp, Line1Product Code
- KGEForceps, Biopsy, Electric2Product Code
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)2Product Code
- KOASurgical Instruments, G-U, Manual (And Accessories)1Product Code
- KQSTable, Cystometric, Non-Electric And Accessories1Product Code
- KQTEvacuator, Gastro-Urology2Product Code
- LQCLithotriptor, Biliary Mechanical2Product Code
- MMZTable, Cystometric, Electric2Product Code
- MNDLigator, Esophageal2Product Code
- NLRUnit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed2Product Code
- NLTSnare, Flexible, Reprocessed2Product Code
- NLUForceps, Biopsy, Electric, Reprocessed2Product Code
- NLVElectrode, Flexible Suction Coagulator, Reprocessed2Product Code
- NLWElectrode, Electrosurgical, Active, Urological, Reprocessed2Product Code
- NQTDislodger, Stone, Flexible, Ureteral, Reprocessed2Product Code
- NQUDislodger, Stone, Basket, Ureteral, Metal, Reprocessed2Product Code
- NWIElectrosurgical Electrode Kit2Product Code
- OLHOrchidometer1Product Code
- ONJDissolvable Gel For Preventing Ureteral Stone Migration2Product Code
- OOWApplicator For Rectal Suppository1Product Code
- PKLHemostatic Metal Clip For The Gi Tract2Product Code
- PLPHigh Intensity Ultrasound System For Prostate Tissue Ablation2Product Code
- PRUGastric Lavage Kit (Adult Or Pediatric Use)2Product Code
- QGBUreteral Stent Accessories1Product Code
- PVYVasovasostomy Set1Product Code
- QAGEndoscopic Electrosurgical Clip Cutting System2Product Code
- LNKLaser For Gastro-Urology Use2Product Code
- MUKElectrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue2Product Code
- NEJSystem, Cryosurgical, Liquid Nitrogen, For Gastroenterology2Product Code
- PZPFluid Jet Removal System2Product Code
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- General HospitalReview Panel
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- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
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- UnknownReview Panel
Gastric Lavage Kit (Adult Or Pediatric Use)
- Page Type
- Product Code
- Definition
- This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Physical State
- This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Technical Method
- This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Target Area
- This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Regulation Medical Specialty
- Gastroenterology and Urology
- Review Panel
- Gastroenterology and Urology
- Submission Type
- Enforcement Discretion
- Device Classification
- Class 2
- Regulation Number
- 876.4370
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 876.4370 Gastroenterology-urology evacuator
§ 876.4370 Gastroenterology-urology evacuator.
(a) Identification. A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.
(b) Classification. (1) Class II (special controls) for the gastroenterology-urology evacuator when other than manually powered. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
(2) Class I for the gastroenterology-urology evacuator when manually powered. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 63 FR 59228, Nov. 3, 1998]