FDA.report

Rectal speculum

Definition
A hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. This is a reusable device.
GUDID devices
426
Last updated
2026-02-25 21:48:26

Related Product Codes

CodeDeviceSpecialtyClassDevices
FFQSpeculum, RectalGastroenterology, Urology1299
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery152
FXESpeculum, Non-IlluminatedGeneral, Plastic Surgery133
FFORetractor, Self-RetainingGastroenterology, Urology117
FGMProbe And Director, Gastro-UrologyGastroenterology, Urology114
LXHOrthopedic Manual Surgical InstrumentOrthopedic15
GADRetractorGeneral, Plastic Surgery14
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology14
GCFProctoscopeGastroenterology, Urology21
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00810158218888PRINCETONPrinceton Medical Group, Inc.69126-01B2026-02-16
00810158218895PRINCETONPrinceton Medical Group, Inc.69126-02B2026-02-16
00810158218901PRINCETONPrinceton Medical Group, Inc.69126-03B2026-02-16
54026704792219PILLINGTELEFLEX INCORPORATEDIPN0179102022-12-08
54026704792226PILLINGTELEFLEX INCORPORATEDIPN0179112022-12-08
00810158218208PRINCETONPrinceton Medical Group, Inc.69226-292026-01-01
00810158218178PRINCETONPrinceton Medical Group, Inc.69121-002025-12-15
00810158218185PRINCETONPrinceton Medical Group, Inc.69127-012025-12-15
00810158218192PRINCETONPrinceton Medical Group, Inc.69127-022025-12-15
00198506085017ELMED INCORPORATEDELMED INCORPORATEDST3037212025-09-05
00190776409180MillenniumAvalign Technologies, Inc.1-EA800R2025-08-22
00190776409265MillenniumAvalign Technologies, Inc.72-303716E2025-08-22
00190776409272MillenniumAvalign Technologies, Inc.72-13475105E2025-08-22
00190776408299MillenniumAvalign Technologies, Inc.72-3040112025-08-07
00194613065607MSI Precision Specialty InstrumentsMed Saver, Inc.91-3385SK2025-08-01
00194613104726MSI Precision Specialty InstrumentsMed Saver, Inc.1921-221BX2025-08-01
00194613120290MSI Precision Specialty InstrumentsMed Saver, Inc.915096102025-08-01
00190776402983MillenniumAvalign Technologies, Inc.72-304502E2025-06-30
00190776399764MillenniumAvalign Technologies, Inc.1-6840380M2025-06-02
04049047074663GimmiGimmi GmbHPU.1616.152025-05-20
04049047074670GimmiGimmi GmbHPU.1618.152025-05-20
04049047074687GimmiGimmi GmbHPU.1622.202025-05-20
04049047074779GimmiGimmi GmbHPU.1660.002025-05-20
04049047316848GimmiGimmi GmbHPU.1630.082025-05-20
00190776393717MillenniumAvalign Technologies, Inc.72-304501F2025-05-06
00190776393724MillenniumAvalign Technologies, Inc.72-304502F2025-05-06
00190776393731MillenniumAvalign Technologies, Inc.72-304503F2025-05-06
00190776393748MillenniumAvalign Technologies, Inc.72-303716F2025-05-06
00190776393755MillenniumAvalign Technologies, Inc.72-304701F2025-05-06
00190776393182MillenniumAvalign Technologies, Inc.1-MB2742025-05-05
B382SD553721F0Surgical DirectSurgical Direct, Inc.SD55-37-21F2025-05-05
00810158214699PRINCETONPrinceton Medical Group, Inc.69126-012025-03-31
00810158214705PRINCETONPrinceton Medical Group, Inc.69126-022025-03-31
B382SD917624150Surgical DirectSurgical Direct, Inc.SD917624152025-01-06
00198506074066ELMED INCORPORATEDELMED INCORPORATED30-34-212025-01-03
00190776389918MillenniumAvalign Technologies, Inc.72-306316F2024-11-18
00190776389130MillenniumAvalign Technologies, Inc.72-304015F2024-11-14
B382SD917670100Surgical DirectSurgical Direct, Inc.SD917670102024-10-24
B382SD917671040Surgical DirectSurgical Direct, Inc.SD917671042024-10-24
00192896120433Chelsea-Eaton SpeculumSONTEC INSTRUMENTS, INC.508-3522024-10-17
04048551229378n.a.Karl Storz GmbH & Co. KG24985AS2017-10-20
04049197258357RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-580-0012024-09-20
00190776383497MillenniumAvalign Technologies, Inc.1-68403602024-08-07
00190776383022MillenniumAvalign Technologies, Inc.1-2020622024-07-24
04048551084830n.a.Karl Storz GmbH & Co. KG24982A2019-02-23
04048551084854n.a.Karl Storz GmbH & Co. KG24982B2019-02-23
04048551084878n.a.Karl Storz GmbH & Co. KG24982C2019-02-23
54026704918619PILLINGTELEFLEX INCORPORATEDIPN0043082024-07-15
54026704918626PILLINGTELEFLEX INCORPORATEDIPN0043092024-07-15
54026704918633PILLINGTELEFLEX INCORPORATEDIPN0043102024-07-15
B382SD9176911030Surgical DirectSurgical Direct, Inc.SD9176911032024-07-09
00842180149038ELMEDELMED INCORPORATED30-37-16F2024-07-05
04049197258494RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-601-1502024-06-28
04049197258500RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-602-0002024-06-28
04049197258524RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-603-1502024-06-28
04049197258579RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-608-0602024-06-28
04049197258609RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-610-1502024-06-28
04049197258623RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-654-0012024-06-28
04049197258630RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-654-0022024-06-28
04049197258647RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-654-0032024-06-28
04049197259095RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-700-0652024-06-28
04049197259118RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-701-0652024-06-28
04049197259132RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-702-0652024-06-28
04049197465526RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-801-1502024-06-28
04049197465557RZ Medizintechnik GmbHRZ-Medizintechnik GmbH310-808-0602024-06-28
00842180195455ELMEDELMED INCORPORATED69127-012024-05-13
00198506001192ELMEDELMED INCORPORATEDST303721F2024-04-24
00198506001208ELMEDELMED INCORPORATEDST3038152024-04-24
00198506001215ELMEDELMED INCORPORATEDST3040152024-04-24
00198506001338ELMEDELMED INCORPORATEDST3046032024-04-24
00198506001376ELMEDELMED INCORPORATEDST305501F2024-04-24
00198506001383ELMEDELMED INCORPORATEDST305502F2024-04-24
00198506001390ELMEDELMED INCORPORATEDST305503F2024-04-24
B382SD556901F0Surgical DirectSurgical Direct, Inc.SD55-69-01F2024-02-09
B382SD556903F0Surgical DirectSurgical Direct, Inc.SD55-69-03F2023-07-13
B382SD556904F0Surgical DirectSurgical Direct, Inc.SD55-69-04F2024-02-09
SD556903F0Surgical DirectSurgical Direct, Inc.SD55-69-03F2023-07-06
B382SD917622170Surgical DirectSurgical Direct, Inc.SD917622172024-03-25
B382SD917622190Surgical DirectSurgical Direct, Inc.SD917622192024-03-25
B382SD9176701100Surgical DirectSurgical Direct, Inc.SD9176701102024-03-25